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L'essai clinique NCT07127159 (IML) pour Accident vasculaire cérébral est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Music Listening for Mental Health Recovery After Stroke (IML) 60 À domicile
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT07127159 (IML) est une étude interventionnel pour Accident vasculaire cérébral. Son statut actuel est : en recrutement. L'étude a débuté le 1 juillet 2025 et vise à recruter 60 participants. Dirigée par l'Université de New York, l'étude devrait être terminée d'ici le 30 septembre 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 25 septembre 2025.
Résumé succinct
This study aims to explore whether listening to music intentionally can support the mental health of people recovering from a stroke. The question the investigators aim to answer is: Can intentional music listening improve emotional well-being in stroke survivors? And if so, what kinds of changes might music listening induce in mental health, thinking and memory (cognition), and brain activity? Participants will be r...Afficher plus
Description détaillée
This is a feasibility clinical trial of a remotely delivered music listening intervention for individuals with chronic stroke, incorporating objective tracking of music exposure and multimodal assessments of mental health, cognitive, neural, and physiological changes.
Specifically, this is a parallel-group randomized controlled feasibility trial enrolling patients with chronic stroke. Participants will be randomized...
Afficher plusTitre officiel
Feasibility of a Music Listening Intervention for Mental Health Recovery in Chronic Stroke
Pathologies
Accident vasculaire cérébralPublications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:Autres identifiants de l'étude
- IML
- FY2024-8826
Numéro NCT
Date de début (réel)
2025-07-01
Dernière mise à jour publiée
2025-09-25
Date de fin (estimée)
2026-09-30
Inscription (estimée)
60
Type d'étude
Interventionnel
PHASE
N/A
Statut
En recrutement
Mots clés
intentional music listening
music intervention
stroke
mental health
stroke recovery
music therapy
emotional well-being
music intervention
stroke
mental health
stroke recovery
music therapy
emotional well-being
Objectif principal
Traitement
Méthode d'allocation
Randomisé
Modèle d'intervention
Parallèle
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalIntentional Music Listening Stroke patients assigned to the Intentional Music Listening group will participate in a 4-week intervention, in which participants will engage in one hour of music listening per day and complete daily self-reports on mood and control measures. Baseline, pre-, and post-intervention evaluations will assess clinical outcomes through behavioral measures of mental health and cognition. Pre- and post-intervention evaluatio...Afficher plus | Intentional Music Listening Participants will receive an iPad with Spotify (for music listening) and FaceTime. For 4 weeks (excluding weekends; 20 sessions), participants will listen to music for one hour per session, without multitasking (e.g., no chores or cooking), and will be encouraged to listen attentively. The investigators will collaborate with each participant to co-create a personalized playlist composed of self-selected, culturally r...Afficher plus |
Comparateur actifAudiobook Listening Stroke patients assigned to the Audiobook Listening group will participate in a 4-week intervention, in which participants will engage in one hour of audiobook listening per day and complete daily self-reports on mood and control measures. Baseline, pre-, and post-intervention evaluations will assess clinical outcomes through behavioral measures of mental health and cognition. Pre- and post-intervention evaluations w...Afficher plus | Audiobook Listening Participants will be provided with an iPad equipped with a Spotify (for audiobook listening) and FaceTime. For 4 weeks (excluding weekends; 20 sessions), participants will be asked to listen to an audiobook of their choice for one hour per session, without engaging in other activities such as chores or cooking. Participants will be instructed to listen attentively and avoid multitasking during the session. A team mem...Afficher plus |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Burden (Completion of evaluation sessions) | Burden associated with each of the four evaluation sessions will be assessed. The outcome measure will include the proportion of patients who complete evaluations at each time point, with a target of at least 80% completion. | From baseline to follow-up (3 months post-intervention) |
Burden Ratings | Investigators will assess the perceived burden of participants by collecting at each evaluation session burden ratings. Participants will rate sessions as "not burdensome," "partially burdensome," or "very burdensome". The goal is for at least 80% of patients to rate the evaluations at each time point as "not burdensome. Burden ratings will be collected at 4 time points (baseline, pre-intervention, post-intervention and follow-up). | From baseline to follow-up (3 months post-intervention) |
Patient acceptability | After each listening session, participants will rate the session as "not acceptable," "partially acceptable," or "fully acceptable." The goal is for at least 80% of sessions to be rated as fully acceptable. | From beginning to end of the intervention (4 weeks) |
Retention and Adherence | Proportion of enrolled and randomized participants who complete the IML/Audiobook sessions. At least 80% of randomized patients complete at least 80% of the IML/Audiobook sessions. | From beginning to end of the intervention (4 weeks) |
Feasibility Ratings | Each listening session will be rated by the study team member leading the session as "not feasible," "partially feasible," or "fully feasible." The primary feasibility outcome measure is the proportion of sessions rated "fully feasible," with a target threshold of 80%. | From beginning to the end of the intervention (4 weeks) |
Fidelity | Fidelity will be measured as the the proportion of listening sessions delivered according to the protocol; video calls with patients will be recorded and a team member who was not present during the call will review the recordings and score the session as "delivered according to protocol" or "not delivered according to protocol". Benchmark for success: At least 80% of all sessions delivered according to the protocol. | From beginning to the end of the intervention (4 weeks) |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Recruitment | Recruitment will be measured by the number of participants successfully enrolled per month. The target benchmark is a minimum of 2 participants enrolled each month. | Baseline |
Randomization (Enrolment) | Randomization will be evaluated based on the proportion of screened participants who are successfully enrolled. The target benchmarks is for at least 30% of screened participants to be enrolled. | Baseline |
Randomization (Participation) | Randomization will be evaluated based on the proportion of enrolled participants who complete both the baseline and pre-intervention evaluations and attend at least one IML or Audiobook session. The target benchmark is for at least 80% of enrolled participants to reach this initial level of study engagement. | Baseline, pre-intervention, and intervention |
Assistant à la participation
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
50 Years
Sexes éligibles
Tous
- Participants aged 50 to 90
- Confirmed diagnosis of ischemic or hemorrhagic stroke occurring at least six months prior to enrollment.
- Significant hearing loss, defined by a score >26 on the Hearing Handicap Inventory for the Elderly Screening (HHIE-S; Ventry and Weinstein, 1982)
- Contraindications for MRI
- Significant cognitive impairment, defined as a Montreal Cognitive Assessment (MoCA; Nasreddine et al., 2005) score below 22 (unless the lower score is attributable to expressive aphasia)
- Specific musical anhedonia, defined as a score below 60 on the Barcelona Music Reward Questionnaire (BMRQ; Mas-Herrero et al., 2013)
- Amusia, defined as a score below 70% on the Montreal Battery of Evaluation of Amusia (MBEA; Peretz et al., 2003).
- Participants will not be excluded if currently taking medications that may affect brain function (e.g., antidepressants) or if engaged in other complementary therapies (e.g., mindfulness, yoga). Participants will be allowed to initiate new medications or therapies during the study period.
Contact central de l'étude
Contact: Pablo Ripolles, PhD, + 1212-998-5424, [email protected]
1 Centres de l'étude dans 1 pays
New York
New York University, New York, New York, 10003, United States
Pablo Ripolles, PhD, Contact, 212-998-5424, [email protected]
Pablo Ripolles, PhD, Investigateur principal
En recrutement